Clinical Trial: Combination Chemotherapy in Treating Young Patients With Langerhans Cell Histiocytosis

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment Protocol of the Third International Study For Langerhans Cell Histiocytosis

Brief Summary:

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of Langerhans cell histiocytosis, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may be an effective treatment for Langerhans cell histiocytosis.

PURPOSE: This randomized clinical trial is studying combination chemotherapy to see how well it works in treating young patients with Langerhans cell histiocytosis.

Detailed Summary:

OBJECTIVES:

Primary

• Compare the efficacy, in terms of response to initial therapy, of prednisolone, vinblastine, and mercaptopurine with vs without methotrexate and leucovorin calcium in young patients with Langerhans cell histiocytosis.
• Compare the progression-free survival of patients with low-risk Langerhans cell histiocytosis who responded to initial therapy who are then treated with 6-month vs 12-month continuation therapy comprising prednisolone and vinblastine.

Secondary

• Compare the acute and long-term toxicity and the incidence of permanent effects.
• Compare the overall and progression-free survival, response rate, and time until response.

OUTLINE: This is a randomized, multicenter study with one pilot nonrandomized stratum. Patients are stratified according to number of systems involved (multiple vs single) and organs involved (at risk vs low risk).

• Stratum 1 (at risk patients): Patients are further stratified according to participating center. Patients are randomized to 1 of 2 treatment arms (arms I and II).

  • Arm I:

    • Initial therapy: Patients receive oral prednisolone 3 times daily on days 1-28 followed by a taper on days 29-42 and vinblastine IV on days 1, 8, 15, 22, 29, and 36. Patients a
      Sponsor: Histiocyte Society
      

      Current Primary Outcome:
      
      

      Original Primary Outcome:
      
      

      Current Secondary Outcome:
      
      

      Original Secondary Outcome:
      
      Information By: National Cancer Institute (NCI)
      

      Dates:
      Date Received: January 12, 2006
      Date Started: April 2001
      Date Completion:
      Last Updated: January 9, 2014
      Last Verified: May 2007